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Rows 1-4: | Show the records for the product identifiers for the tobacco product identified in SPTOBID. These records are categorized as product identifiers by TOCAT = PRODUCT IDENTIFIERS. |
---|---|
Rows 5-10: | Show the records for the product descriptors for the tobacco product identified in SPTOBID. These records are categorized as product identifiers by TOCAT = PRODUCT DESCRIPTOR. |
to.xpt
Row
STUDYID
DOMAIN
SPTOBID
TOSEQ
TOTESTCD
TOTEST
TOCAT
TOORRES
TOORRESU
TOSTRESC
TOSTRESN
TOSTRESU
1
title | tx.xpt (trial sets) |
---|
trial sets) |
- During CT definition/reviews will decide appropriate TXPARM and TXVAL; Treatment duration may be controlled; For now, we just include good example values based on our experience
- Assumption: The Trial Sets (TX) domain provides the list of distinct sets of subjects having different experimental factors, treatment factors, inherent characteristics, or distinct sponsor designations as specified in the trial design.
- Where is TK6 cell type? is this test system (see below)
- needs to be allowed to vary down to the well level / result level
- Assumption: SPDEVID (sponsor defined device identifier), and Test System should be added at the trial set level (tx.xpt). While it is possible to show a value in TS when there is only one device for a study, we will make it a rule that it goes in TX for consistency and cross-study analysis.
- This allows for studies where there are multiple products and different product(s) per trial set, one record for each product that is being tested in each particular trial set (tx.xpt)
- Assumption: SPDEVID and DUREFID should only be in TX (with the same value for all sets if there is only one device used)
- Assumption: SPDEVID (sponsor defined device identifier) should be added at the trial set level (tx.xpt). While it is possible to show a value in TS when there is only one device for a study, we will make it a rule that it goes in TX for consistency and cross-study analysis.
- This allows for studies where there are multiple products and different product(s) per trial set, one record for each product that is being tested in each particular trial set (tx.xpt)
- Do we need both SPDEVID AND DUREFID?
- What are good values (realistic) for "SET"?
- Check Essential Data list
A1:
A2:
Row | STUDYID | ASSAYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL |
---|---|---|---|---|---|---|---|---|---|
1 | 123 | MNvit | TX | A1 (table 1, row 1, ST exposure with S9) | ST+S9C0 | 1 | TESTSYS | Test system | TK6 Lymphoblastoid Suspension Cells |
2 | 123 | MNvit | TX | A1 | ST+S9C0 | 2 | METACT | Metabolic Activation (this is the type of activation used) | +S9 |
3 | 123 | MNvit | TX | A1 | ST+S9C0 | 3 | METACTFL | Y/N presence of metabolic activation (this indicates that metabolic activation was used) | Y |
4 | 123 | MNvit | TX | A1 | ST+S9C0 | 4 | TRTDMIN | Treatment Duration Minimum | 3 |
5 | 123 | MNvit | TX | A1 | ST+S9C0 | 5 | TRTDTRG | Treatment Duration Target | 3.5 |
6 | 123 | MNvit | TX | A1 | ST+S9C0 | 6 | TRTDMAX | Treatment Duration Maximum | 4 |
7 | 123 | MNvit | TX | A1 | ST+S9C0 | 7 | TRTDU | Treatment Duration Unit | HOURS |
8 | 123 | MNvit | TX | A1 | ST+S9C0 | 8 | RCVDMIN | Recovery Duration Minimum | 23.5 |
9 | 123 | MNvit | TX | A1 | ST+S9C0 | 9 | RCVDTRG | Recovery Duration Target | 24 |
10 | 123 | MNvit | TX | A1 | ST+S9C0 | 10 | RCVDMAX | Recovery Duration Maximum | 24.5 |
11 | 123 | MNvit | TX | A1 | ST+S9C0 | 11 | RCVDU | Recovery Duration Unit | HOURS |
12 | 123 | MNvit | TX | A1 | ST+S9C0 | 12 | INCBTMP | Incubation Temperature | 37 |
13 | 123 | MNvit | TX | A1 | ST+S9C0 | 13 | INCBTMPU | Incubation Temperature Unit | C |
14 | 123 | MNvit | TX | A1 | ST+S9C0 | 14 | HUMID | Atmospheric Relative Humidity Percent | 50 |
15 | 123 | MNvit | TX | A1 | ST+S9C0 | 15 | ATMCO2 | Atmospheric CO2 Percent | 5 |
16 |
- During CT definition/reviews will decide appropriate TXPARM and TXVAL; Treatment duration may be controlled; For now, we just include good example values based on our experience
- Assumption: The Trial Sets (TX) domain provides the list of distinct sets of subjects having different experimental factors, treatment factors, inherent characteristics, or distinct sponsor designations as specified in the trial design.
- Where is TK6 cell type? is this test system (see below)
- needs to be allowed to vary down to the well level / result level
- Assumption: SPDEVID (sponsor defined device identifier), and Test System should be added at the trial set level (tx.xpt). While it is possible to show a value in TS when there is only one device for a study, we will make it a rule that it goes in TX for consistency and cross-study analysis.
- This allows for studies where there are multiple products and different product(s) per trial set, one record for each product that is being tested in each particular trial set (tx.xpt)
- Assumption: SPDEVID and DUREFID should only be in TX (with the same value for all sets if there is only one device used)
- Assumption: SPDEVID (sponsor defined device identifier) should be added at the trial set level (tx.xpt). While it is possible to show a value in TS when there is only one device for a study, we will make it a rule that it goes in TX for consistency and cross-study analysis.
- This allows for studies where there are multiple products and different product(s) per trial set, one record for each product that is being tested in each particular trial set (tx.xpt)
- Do we need both SPDEVID AND DUREFID?
- What are good values (realistic) for "SET"?
- Check Essential Data list
A1:
A2:
Row | STUDYID | ASSAYID | DOMAIN | SETCD | SET | TXSEQ | TXPARMCD | TXPARM | TXVAL | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | 123 | MNvit | TX | A1 (table 1, row 1, ST exposure with S9) | ST+S9C0 | 16 | SPTOBID (links to to.xpt, tobacco identifiers, the design parameters of the tobacco product) | Sponsor defined tobacco identifier | CIG01a | ||||||||||||
17 | 123 | MNvit | TX | A1 | ST+S9C0 | 117 | TESTSYS | Test system | TK6 Lymphoblastoid Suspension Cells | EXPTYP | Exposure Type (See TIG NC workstream minutes 30-Jan here: Nonclinical) | Submerged | |||||||||
182 | 123 | MNvit | TX | A1 | ST+S9C0 | 2 | METACT | Metabolic Activation (this is the type of activation used) | 18 | SAMTYP | Sample Type (e.g. TPM, GVP, whole aerosol, whole smoke conditioned media, aqueous extracts, etc., see notes here: Nonclinical) | Total Particulate Matter in DMSO | |||||||||
19 | +S9 | 3 | 123 | MNvit | TX | A1 | ST+S9C0 | 319 | METACTFL | Y/N presence of metabolic activation (this indicates that metabolic activation was used) | Y | INTRVN | Name of the Intervention Article can be: Tobacco ProdA, Bleomycin (positive control) or Cyclophosphamid A (positive control) | Tobacco ProdA | |||||||
204 | 123 | MNvit | TX | A1 | ST+S9C0 | 420 | TRTDMIN | Treatment Duration Minimum | 3 | ||||||||||||
5 | 123 | MNvit | TX | A1 | ST+S9C0 | 5 | TRTDTRG | Treatment Duration Target | 3.5 | ||||||||||||
ITVTYPE | type of intervention article choices of values: product; negative control; positive control | Negative Control | |||||||||||||||||||
216 | 123 | MNvit | TX | A1 | ST+S9C0 | 621 | TRTDMAX | Treatment Duration Maximum | 4 | ITVCONC | Concentration of intervention article | 0 | |||||||||
227 | 123 | MNvit | TX | A1 | ST+S9C0 | 722 | TRTDUITVCONCU | Treatment Duration Concentration Unit | HOURSug/ml | ||||||||||||
823 | 123 | MNvit | TX | A1 | ST+S9C0 | 8 | RCVDMIN | Recovery Duration Minimum | 23 | SPDEVID (links to di.xpt, unique device identification, e.g. device type, manufacturer,etc. ) | Sponsor defined device identifier | PUFFMASTER3K | |||||||||
24 | 23.5 | 9 | 123 | MNvit | TX | A1 | ST+S9C0 | 24 | 9 | RCVDTRG | Recovery Duration Target | 24 | DUREFID (links to du.xpt, device in use properties) | Smoke Regimen | Medium Intensity Regimen | ||||||
25 | 10123 | MNvit | TX | A1 | ST+S9C0 | 10 | RCVDMAX | Recovery Duration Maximum | 24.5 | ||||||||||||
11 | 123 | MNvit | TX | A1 | ST+S9C0 | 11 | RCVDU | Recovery Duration Unit | HOURS | ||||||||||||
A2 (table 1, row 2, ST exposure with S9 at concentration 1250) | ST+S9-1250 | 1 | TESTSYS | Test system | TK6 Lymphoblastoid Suspension Cells | ||||||||||||||||
26 | 12123 | MNvit | TX | A1A2 | ST+ | S9C0S9-1250 | 122 | INCBTMP | Incubation Temperature | 37 | METACT | Metabolic Activation (this is the type of activation used) | +S9 | ||||||||
27 | 13123 | MNvit | TX | A1A2 | ST+ | S9C0S9-1250 | 133 | INCBTMPU | Incubation Temperature Unit | C | METACTFL | Y/N presence of metabolic activation (this indicates that metabolic activation was used) | Y | ||||||||
28 | 14123 | MNvit | TX | A1A2 | ST+ | S9C0S9-1250 | 144 | HUMID | Atmospheric Relative Humidity Percent | 50 | TRTDMIN | Treatment Duration Minimum | 3 | ||||||||
29 | 15123 | MNvit | TX | A1A2 | ST+ | S9C0S9-1250 | 155 | ATMCO2 | Atmospheric CO2 Percent | TRTDTRG | Treatment Duration Target | 3.5 | |||||||||
30 | 123 | MNvit | TX | A1A2 | ST+ | S9C0S9-1250 | 166 | SPTOBID | Sponsor defined tobacco identifier | CIG01a | TRTDMAX | Treatment Duration Maximum | 4 | ||||||||
31 | 17123 | MNvit | TX | A1A2 | ST+ | S9C0S9-1250 | 177 | EXPTYP | Exposure Type (See TIG NC workstream minutes 30-Jan here: Nonclinical) | Submerged | TRTDU | Treatment Duration Unit | HOURS | ||||||||
32 | 18123 | MNvit | TX | A1A2 | ST+ | S9C0S9-1250 | 188 | SAMTYP | Sample Type (e.g. TPM, GVP, whole aerosol, whole smoke conditioned media, aqueous extracts, etc., see notes here: Nonclinical) | Total Particulate Matter in DMSO | RCVDMIN | Recovery Duration Minimum | 23.5 | ||||||||
33 | 19123 | MNvit | TX | A1A2 | ST+ | S9C0S9-1250 | 199 | INTRVN | Name of the Intervention Article can be: Tobacco ProdA, Bleomycin (positive control) or Cyclophosphamid A (positive control) | Tobacco ProdA | RCVDTRG | Recovery Duration Target | 24 | ||||||||
34 | 20123 | MNvit | TX | A1A2 | ST+ | S9C0S9-1250 | 2010 | ITVTYPE | type of intervention article choices of values: product; negative control; positive control | Negative Control | RCVDMAX | Recovery Duration Maximum | 24.5 | ||||||||
35 | 21123 | MNvit | TX | A1A2 | ST+ | S9C0S9-1250 | 2111 | ITVCONC | Concentration of intervention article | 0 | RCVDU | Recovery Duration Unit | HOURS | ||||||||
36 | 22123 | MNvit | TX | A1A2 | ST+ | S9C0S9-1250 | 2212 | ITVCONCUINCBTMP | Concentration Unit | ug/ml | Incubation Temperature | 37 | |||||||||
37 | 23123 | MNvit | TX | A1A2 | ST+ | S9C0S9-1250 | 2313 | SPDEVID | Sponsor defined device identifier | PUFFMASTER3K | INCBTMPU | Incubation Temperature Unit | C | ||||||||
38 | 24123 | MNvit | TX | A1A2 | ST+ | S9C0S9-1250 | 2414 | DUREFID | Smoke Regimen | Medium Intensity Regimen | HUMID | Atmospheric Relative Humidity Percent | 50 | ||||||||
3925 | 123 | MNvit | TX | A2 | (table 1, row 2, ST exposure with S9 at concentration 1250)ST+S9-1250 | 115 | TESTSYS | Test system | TK6 Lymphoblastoid Suspension Cells | ATMCO2 | Atmospheric CO2 Percent | 5 | |||||||||
40 | 26123 | MNvit | TX | A2 | ST+S9-1250 | 216 | METACT | Metabolic Activation (this is the type of activation used) | +S9 | SPTOBID | Sponsor defined tobacco identifier | CIG01a | |||||||||
41 | 27123 | MNvit | TX | A2 | ST+S9-1250 | 3 | METACTFL | Y/N presence of metabolic activation (this indicates that metabolic activation was used) | Y | 17 | EXPTYP | Exposure Type (See TIG NC workstream minutes 30-Jan here: Nonclinical) | Submerged | ||||||||
42 | 28123 | MNvit | TX | A2 | ST+S9-1250 | 4 | TRTDMIN | Treatment Duration Minimum | 3 | 18 | SAMTYP | Sample Type (e.g. TPM, GVP, whole aerosol, whole smoke conditioned media, aqueous extracts, etc., see notes here: Nonclinical) | Total Particulate Matter in DMSO | ||||||||
43 | 29123 | MNvit | TX | A2 | ST+S9-1250 | 519 | TRTDTRG | Treatment Duration Target | 3.5 | INTRVN | Name of the Intervention Article | Tobacco ProdA | |||||||||
44 | 30123 | MNvit | TX | A2 | ST+S9-1250 | 6 | TRTDMAX | Treatment Duration Maximum | 4 | 20 | ITVTYPE | type of intervention article choices of values: product; negative control; positive control | Product | ||||||||
45 | 31123 | MNvit | TX | A2 | ST+S9-1250 | 721 | TRTDU | Treatment Duration Unit | HOURS | ITVCONC | Concentration of intervention article | 1250 | |||||||||
46 | 32123 | MNvit | TX | A2 | ST+S9-1250 | 822 | RCVDMIN | Recovery Duration Minimum | 23.5 | ITVCONCU | Concentration Unit | ug/ml | |||||||||
47 | 33123 | MNvit | TX | A2 | ST+S9-1250 | 923 | RCVDTRG | Recovery Duration Target | 24 | SPDEVID | Sponsor defined device identifier | PUFFMASTER2023 | |||||||||
48 | 34123 | MNvit | TX | A2 | ST+S9-1250 | 10RCVDMAX | Recovery Duration Maximum | 24 | .535 | DUREFID | 123 | MNvit | TX | A2 | ST+S9-1250 | 11 | RCVDU | Recovery Duration Unit | HOURS | ||
36 | 123 | MNvit | TX | A2 | ST+S9-1250 | 12 | INCBTMP | Incubation Temperature | 37 | ||||||||||||
37 | 123 | MNvit | TX | A2 | ST+S9-1250 | 13 | INCBTMPU | Incubation Temperature Unit | C | ||||||||||||
38 | 123 | MNvit | TX | A2 | ST+S9-1250 | 14 | HUMID | Atmospheric Relative Humidity Percent | 50 | ||||||||||||
39 | 123 | MNvit | TX | A2 | ST+S9-1250 | 15 | ATMCO2 | Atmospheric CO2 Percent | 5 | ||||||||||||
40 | 123 | MNvit | TX | A2 | ST+S9-1250 | 16 | SPTOBID | Sponsor defined tobacco identifier | CIG01a | ||||||||||||
41 | 123 | MNvit | TX | A2 | ST+S9-1250 | 17 | EXPTYP | Exposure Type (See TIG NC workstream minutes 30-Jan here: Nonclinical) | Submerged | ||||||||||||
42 | 123 | MNvit | TX | A2 | ST+S9-1250 | 18 | SAMTYP | Sample Type (e.g. TPM, GVP, whole aerosol, whole smoke conditioned media, aqueous extracts, etc., see notes here: Nonclinical) | Total Particulate Matter in DMSO | ||||||||||||
43 | 123 | MNvit | TX | A2 | ST+S9-1250 | 19 | INTRVN | Name of the Intervention Article | Tobacco ProdA | ||||||||||||
44 | 123 | MNvit | TX | A2 | ST+S9-1250 | 20 | ITVTYPE | type of intervention article choices of values: product; negative control; positive control | Product | ||||||||||||
45 | 123 | MNvit | TX | A2 | ST+S9-1250 | 21 | ITVCONC | Concentration of intervention article | 1250 | ||||||||||||
46 | 123 | MNvit | TX | A2 | ST+S9-1250 | 22 | ITVCONCU | Concentration Unit | ug/ml | ||||||||||||
47 | 123 | MNvit | TX | A2 | ST+S9-1250 | 23 | SPDEVID | Sponsor defined device identifier | PUFFMASTER2023 | ||||||||||||
48 | 123 | MNvit | TX | A2 | ST+S9-1250 | 24 | DUREFID | Smoke Regimen | High Intensity Regimen | ... |
title | du.xpt smoke regimen definition (a findings domain for device in-use properties) |
---|
We use DU for smoking regimen. Note that a separate DI dataset will be needed to show identifying parameters of the "PUFFMASTER3K" smoking machine
- Details of the smoking regimen are represented as device in-use properties, linked to the stability data in PT above by matching values of PTREFID/DUREFID = "Medium Intensity Regimen" (We will update with a realistic value for the regimen, with input).
- Smoking regimen is represented in --REFID (we made up a value of "Medium Intensity Regimen"; we can update with something realistic)
- The smoking regimen is carried out by the smoking machine/device shown in SPDEVID, Sponsor defined device identifier, "PUFFMASTER3K"
du.xpt
Row
STUDYID
DOMAIN
SPDEVID
DUSEQ
DUREFID
DUGRPID
DUTESTCD
DUTEST
DUORRES
DUORRESU
DUSTRESC
DUSTRESN
DUSTRESU
PUFFDUR
1.25
sec
1.25
sec
PUFFINT
3
PUFF/min
3
PUFF/min
PUFFBLCK
25
%
25
%
200
PUFF
200
PUFF
10
mL
10
mL
100-200
100-200
60
s
60
s
10
PUFF
10
PUFF
Canadian Intense Regime
PUFFDUR
2.00
sec
2.00
sec
PUFFINT
4
PUFF/min
4
PUFF/min
Canadian Intense Regime
PUFFBLCK
0
%
0
%
200
PUFF
200
PUFF
10
mL
10
mL
Canadian Intense Regime
100-200
100-200
Smoke Regimen | High Intensity Regimen | ||||||||
... |
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(This is a copy from the SDTM Example. Cigarette Design Parameters, will need scription team)
to.xpt
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di.xpt (copied v1.0 of medical devices IG)
Example 1
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We use DU for smoking regimen. Note that a separate DI dataset will be needed to show identifying parameters of the "PUFFMASTER3K" smoking machine
du.xpt
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17 | 123 | DU | PUFFMASTER2023 | 8 | Canadian Intense Regime | 1 | PUFFPAUS | Puff Pause | 60 | s | 60 | 60 | s | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
18 | 123 | DU | PUFFMASTER2023 | 9 | Canadian Intense Regime | 1 | PUFFPINT | Puff Pause Interval | 10 | PUFF | 10 | 10 | PUFF | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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di.xpt (copied v1.0 of medical devices IG)
Example 1
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